DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM DEXCOM SHARE SYSTEM

MDR report key: 5229553 · Received November 17, 2015

Report

Report Number: 3004753838-2015-66613
Event Type: Malfunction
Date Received: November 17, 2015
Date of Event: October 19, 2015
Report Date: October 23, 2015
Manufacturer: DEXCOM, INC.
Product Code: MDS
PMA / PMN Number: P120005
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: FL, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(6).

Additional Manufacturer Narrative · 1

(B)(4).

Description of Event or Problem · 1

PATIENT'S MOTHER CONTACTED DEXCOM ON (B)(6) 2015, TO REPORT THAT ON (B)(6) 2015 THE PATIENT'S RECEIVER HAD UNRECOVERABLE LOSS OF ANTENNA. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. THE DEVICE HAS BEEN RECEIVED FOR EVALUATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE EVALUATION IS COMPLETE.

Description of Event or Problem · 1

PATIENT'S MOTHER CONTACTED DEXCOM ON (B)(6) 2015, TO REPORT THAT ON (B)(6) 2015 THE PATIENT'S RECEIVER HAD UNRECOVERABLE LOSS OF ANTENNA. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. SUBSEQUENT TO THE INITIAL MDR, THE COMPLAINT RECEIVER WAS NOT RETURNED TO DEXCOM. THE TRANSMITTER (PART NUMBER STT-GL-003/SERIAL NUMBER (B)(4)/LOT NUMBER 5200720), BEING USED WITH THE COMPLAINT RECEIVER, WAS RETURNED ON (B)(4) 2015. THE RETURNED TRANSMITTER WAS VISUALLY INSPECTED AND NO DEFECT WAS FOUND. FUNCTIONAL TESTING WAS PERFORMED AND THE TEST FAILED. THE REPORTED EVENT OF AN UNRECOVERABLE LOSS OF ANTENNA WAS CONFIRMED. THE ROOT CAUSE WAS DETERMINED TO BE A DEFECTIVE TRANSMITTER.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
760184	DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM DEXCOM SHARE SYSTEM	MDS	MDS	DEXCOM, INC.	MT22608-PNK	5201238

Patients

Seq	Age	Sex	Outcome	Treatment
1	12 YR